The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
研究概览
简要总结
Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.
详细描述
Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.
Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:
A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.
C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participant was blinded, the first assistant who explained the pain scale to the participants and asked him\her to record the score of pain associated with the drug administration was also blinded.
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •uncooperative children scored 1 or 2 on Frankle Scale.
- •had no medical history of neurological or cognitive alterations.
- •No facial deformities.
- •ASA Classification I.
- •requiring dental treatment under local anesthesia.
排除标准
- •known allergy to midazolam or any other benzodiazepines.
- •upper respiratory tract infection with nasal discharge.
研究组 & 干预措施
A (Midazolam)
21 children received 0.5 mg/kg intranasal medication (midazolam), with a maximum dose of 10 mg, via a spray of 0.2 ml per puff, administering the drug was alternated between the two nostrils of the child.
干预措施: Midazolam (Drug)
B (Lidocaine-Midazolam)
21 children received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg intranasal medication (midazolam),administering the drug was alternated between the two nostrils of the child, with a maximum dose of 10 mg via a spray of 0.2 ml per puff.
干预措施: Lidocaine-Midazolam (Drug)
C (Placebo)
21 children received intranasal medication (saline 9% as placebo), 0.5 mg/kg, with a maximum dose of 10 mg via a spray of 0.2 ml per puff,administering the drug was alternated between the two nostrils of the child.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
时间窗: one to five minutes following the administration.
The use of intranasal midazolam is associated with a burning sensation of the nasal mucosa, the pain was assessed using a self report pain scale Wong Baker Faces Scale, the degree of pain is determined by choosing a score of (0-2-4-6-8-10) (minimum score 0, means no pain, maximum score 10, means the drug hurts worst, higher scores are worse) the scores were reported by children received intranasal midazolam alone, intranasal midazolam preceded by intranasal lidocaine or intranasal saline (placebo).
次要结局
未报告次要终点
研究者
Nabih Raslan
Principal Investigator
Tishreen University